| Primary | Number of Participants Who Developed Toxicity Requiring Discontinuation From Study Treatment During Cycle 1 | Tolerability of ofatumumab in combination with chlorambucil was evaluated based on the number of participants who developed toxicity requiring discontinuation from study treatment during Cycle 1. The treatment was considered tolerable when 0 of 3 participants, or <=2 of 6 participants developed toxicity which required discontinuation of study treatment during Cycle 1. The toxicity requiring discontinuation was determined based on the pre-defined withdrawal criteria. | All Subjects Population: all participants who received at least one dose of investigational product. | Posted | | Number | | Participants | | From start of treatment through Cycle 1 (Week 4) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Primary | Number of Participants With Overall Response, as Assessed by the Independent Review Committee (IRC) With CT, IRC and Investigator | Response evaluated as per International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-sponsored Working Group (NCI-WG) Guidelines, 2008. Overall response rate (ORR) is defined as percentage of par. achieving complete remission (CR), nodular partial remission (nPR), CR-incomplete (CRi) or PR. CR (>=2 months after last treatment): lymphocytes (LC) <4000 per microliter (μL), no lymphadenopathy (Ly)>1.5 cm/hepatomegaly/splenomegaly/constitutional symptoms; neutrophils (N)>1500/µL, platelets (PL)>100,000/µL, hemoglobin (Hb)>11 grams/deciliter (g/dL), bone marrow (BM) sample must be normocellular for age,<30% LC, no lymphoid nodule (LN). PR:>=50% decrease in LC, Ly, size of liver and spleen; and at least one of these: N>1500/μL, PL>100,000/µL or 50% improvement over Baseline (BL), Hb>11 g/dL or 50% improvement over BL. nPR: persistent nodules BM. CRi: CR criteria, persistent anemia/thrombocytopenia/neutropenia unrelated to CLL but related to drug toxicity. | | Posted | | Number | | Participants | | From start of treatment until disease progression or death (up to Week 62.3) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Number of Participants With CR, as Assessed by the IRC, IRC With CT, and the Investigator | Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, CR (all the criteria at least 2 months after last treatment): peripheral blood lymphocytes below < 4,000/μL, no Ly > 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; Neu >1500 /µL, PL >100,000/µL, Hb >11 g/dL, BM sample must be normocellular for age, <30% lymphocytes, no LN. PR: >=50% decrease in peripheral blood lymphocytes, Ly, size of liver and spleen; and blood count showing at least one of the following results: Neu>1500/μL, PL >100,000/µL or 50% improvement over BL, Hb >11 g/dL or 50% improvement over BL. No increase in LN and no new LN. | | Posted | | Number | | Participants | | From start of treatment until disease progression or death (up to Week 62.3) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Progression-free Survival (PFS), as Assessed by the IRC and the Investigator | Progression free survival is defined as the time from start of treatment until disease progression (PD) or death due to any cause. PD was determined by the IRC or investigator according to the definitions of response in the IWCLL updated NCI-WG guidelines, 2008. According to the guidelines, PD is characterized by at least one of the following: lymphadenopathy (appearance of any new lesion such as enlarged lymph nodes (>1.5 centimeter [cm]), spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site); an increase by 50% or more in the previously noted enlargement of the liver or spleen; an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 per microliter B-lymphocytes; transformation to a more aggressive histology; or occurrence of cytopenia attributable to chronic lymphocytic leukemia. PFS was censored at the last visit with adequate assessment for participants who were alive and had not progressed. | All Subjects Population. Only participants who progressed or died were analyzed. | Posted | | Median | 95% Confidence Interval | Weeks | | From start of treatment until disease progression or death (up to Week 62.3) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Overall Survival | Overall survival is defined as time from start of treatment until death due to any cause. For participants who did not die, time to death was censored at the time of the last date of contact. | | Posted | | Median | 95% Confidence Interval | Weeks | | From start of treatment until death (up to Week 62.3 | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Time to Response, as Assessed by the IRC | Time to response is defined as the time from start of treatment until the first response (CR/CRi/nPR/PR). Response was determined according to the IWCLL updated NCI-WG guidelines, 2008. This analysis only included participants who had a response while in the study, there was no censoring. | All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated. | Posted | | Median | 95% Confidence Interval | Weeks | | From start of treatment until the first response (CR/CRi/nPR/PR) (up to Week 62.3) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Duration of Response, as Assessed by the IRC | Duration of response is defined as the time from the first documented evidence of CR, CRi, nPR or PR until the first documented sign of PD or death in participants with CR, CRi, nPR or PR. For participants who did not progress or die, duration of response was censored on the date of last assessment. | All Subjects Population. Only those participants classified as responders (CR, CRi, PR, nPR) were evaluated. | Posted | | Median | 95% Confidence Interval | Weeks | | From initial response (CR/CRi/nPR/PR) until disease progression or death (up to Week 62.3) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Time to Next Chronic Lymphocytic Leukemia (CLL) Therapy | Time to next CLL therapy is defined as the time from start of treatment until the first administration of the next CLL treatment other than chlorambucil administrations scheduled in this study. Time to next CLL therapy was restricted to the subgroup of the population who receive a next CLL therapy after experiencing disease progression. | All Subjects Population. Only those participants who received next CLL therapy were evaluated. | Posted | | Median | 95% Confidence Interval | Weeks | | From start of treatment until the first administration of the next CLL therapy (up to Week 62.3) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Number of Participants With no B-symptoms (Constitutional Symptoms) and With at Least One B-symptom (Constitutional Symptoms) at the Indicated Time Points | The number of participants with no B-symptoms (no night sweat [without signs of infection], no unexplained, unintentional weight loss >= 10% within the previous 6 months, no recurrent, unexplained fever of greater than 38 degrees celcius for 2 weeks and no extreme fatigue) and the number of participants with at least one of the B-symptoms are summarized by assessment time. The presence of the B-symptoms was assessed at Baseline, Day 1 of each treatment cycle and follow-up (FU). Baseline was the last pre-dose assessment performed at Cycle (C) 1-Day (D) 1. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | | Number | | Participants | | Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Number of Participants With Improvement in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG PS is a scale to assess disease progression, extent to which disease affects the daily living abilities and determines appropriate treatment and prognosis. It is scored on a scale of 0 to 5 as, 0 (fully active), 1 (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), 2 (ambulatory and capable of all self cares but unable to carry out any work activities, up and about > 50% of waking hours), 3 (capable of only limited self cares, confined to bed or chair > 50% of waking hours), 4 (completely disabled, cannot carry on any self cares, totally confined to bed or chair), 5 (death). Improvement is defined as decrease from Baseline by at least one step on the ECOG performance status scale (yes/no). Baseline was the last pre-dose assessment performed on Cycle 1-Day 1(C1-D1). When C1-D1 was missing, the last assessment performed prior to pre-dose C1-D1 was used. It was performed on Day 1 of each cycle and follow-up (FU). | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population. | Posted | | Number | | Participants | | Baseline, C2-D29, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9 -D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | |
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| Secondary | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed. | | Posted | | Number | | Participants | | From start of treatment until follow-up for survival (up to Week 62.3) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Number of Participants With AEs of Maximum Severity | Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator. | | Posted | | Number | | Participants | | From start of treatment until follow-up for survival (up to Week 62.3) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events | Adverse events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) grade, version 4.03 (1=mild; 2=moderate; 3=severe; 4=life-threatening/disabling; 5=death). AEs not in the list of CTCAE were graded at discretion of the investigator. Myelosuppression is defined as the decrease in the ability of the bone marrow to produce blood cells. Participants with Grade (G)3 or G4 adverse event of infection and myelosuppression (anemia, neutropenia, and thrombocytopenia) are presented. Also presented are number of participants with autoimmune hemolytic anemia (AIHA). AIHA is a disease where the body's immune system fails to recognize red blood cells as "self" and begins destroying these red blood cells. | | Posted | | Number | | Participants | | From start of treatment until follow-up for survival (up to Week 62.3) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Number of Participants With the Indicated Results for Human Anti-human Antibody (HAHA) at the Indicated Time Points | HAHA are indicators of immunogenicity induced by ofatumumab. Blood samples were taken from participants at Screening, Cycle 4-Day 85, FU 1-PDFU 1, and FU 169-PDFU 169. The presence of HAHA in human serum was determined using a validated electrochemiluminescent assay in a multi-tier assay format. The results are presented as participants with HAHA results as positive, negative or confirmation required. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects Population. | Posted | | Number | | Participants | | Screening, Cycle 4-Day 85, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Mean Change From Baseline in the Immunoglobulins (Ig) Antibodies IgA, IgG, and IgM at the Indicated Time Points | Immunoglobulins, or antibodies, are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Baseline IgA, IgG, and IgM values are the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Immunoglobulins were measured at Cycle 1-Day 1, FU 1-PDFU 1, and FU 169-PDFU 169 for participants in CR, PR, and stable disease (SD). | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population. | Posted | | Mean | Standard Deviation | Grams per liter | | Baseline (Cycle 1-Day 1), FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), and FU 169-PDFU 169 (168 days after FU-1) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Number of Participants Who Were Positive or Negative for Minimal Residual Disease (MRD), as Assessed by IRC With CT | MRD refers to small number of leukemic cells that remain in the participant's body during treatment or after treatment in participants who achieved a confirmed complete remission. MRD assessment in bone marrow aspiration sample was perfrmed by flow cytometry (cluster of differentiation [CD]5, CD19, CD20, CD23). The absence of MRD was defined as less than one CLL cell per 10,000 leukocytes. The number of participants who were positive and negative for MRD are presented. | All Subjects Population. Only those participants who were positive and negative for MRD were analyzed. | Posted | | Number | | Participants | | FU 85-PDFU 85 (84 days after FU-1) | | | | ID | Title | Description |
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| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Change From Baseline in CD5+CD19+ and CD5-CD19+ Cell Counts at the Indicated Time Points | CD5+CD19+ cells were counted in peripheral blood by flow cytometry. Baseline CD5+CD19+ and CD5-CD19+ cell count value is the last pre-dose assessment values performed on Cycle 1-Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. B-cell monitoring (CD5+CD19+ and CD5-CD19+) was performed at Cycle 1 (Day 1, Day 15) and Cycle 2 (Day 29, Day 43), on Day 1 of Cycle 3, 4, 5, 6, 9 and 12 (Day 57, Day 85, Day 113, Day 141, Day 225, Day 309), 28 days after the first day of the last treatment cycle (FU 1-PDFU 1) for all participants depending on the number of cycles administered, and 84 and 168 days after the day of FU 1-PDFU 1 for participants in CR, PR, and SD. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects population. | Posted | | Mean | Standard Deviation | Cells per microliter | | Baseline, C1-D15, C2-D29, C2-D43, C3-D57, C4-D85, C5-D113, C6-D141, C7-D169, C8-D197, C9-D225, FU 1-PDFU 1 (28 days post Day 1 of Last Cycle), FU 85-PDFU 85 (84 days after FU-1), and FU 169-PDFU 169 (168 days after FU-1) | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Beta-2 Microglobulin at Cycle 1-Day 1 | Beta-2-microglobulin is a protein present on the surface of most cells. Higher levels indicate a poor prognosis of CLL. Beta-2 microglobulin was measured at Cycle 1-Day 1. | | Posted | | Mean | Standard Deviation | Nanomoles per liter (NMOL/L) | | Cycle 1-Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
| |
| Secondary | Complement (CH50) at Cycle 1-Day 1 and Cycle 4-Day 85 | The CH50 is the serum complement to lyse 50% of sensitized red blood cells; it is a marker of complement activation. A high CH50 level suggests evidence for complement activation, whereas a low CH50 level suggests lack of complement activation. Peripheral blood samples were collected for analysis at Cycle 1-Day 1 and Cycle 4-Day 85. | All Subjects Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the All Subjects pPopulation. | Posted | | Mean | Standard Deviation | Kilo units per liter (KU/L) | | Cycle 1-Day 1 and Cycle 4-Day 85 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Maximum (Peak) Plasma Concentration (Cmax) of Ofatumumab | Maximum (peak) plasma drug concentration of ofatumumab was determined at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr). | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | Micrograms/milliliter (µg/mL) | | Cycle 1-Day 1 and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Overall Study Arm | ar. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Cmax of Serum Chlorambucil | Cmax of serum chlorambucil was assesed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab +Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Cmax of Serum Phenyl Acetic Acid Mustard | Cmax of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Minimum Plasma Concentration (Cmin) of Ofatumumab | Minimum plasma drug concentration of ofatumumab was determined at Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr), Cycle 2-Day 29 (pre-dose), Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr), Cycle 4-Day 85 (pre-dose, 30 min post end of infusion), Cycle 5-Day 113 (pre-dose and end of infusion) and Cycle 6-Day 141 (pre-dose and end of infusion). | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | Micrograms/milliliter (µg/mL) | | Cycle 1-Day 8, Cycle 2-Day 29, Cycle 3-Day 57, Cycle 4-Day 85, Cycle 5-Day 113, and Cycle 6-Day 141 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Cmin of Chlorambucil | Cmin of chlorambucil was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Mean | 95% Confidence Interval | ng/mL | | Cycle 1-Day 4 and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Cmin of Phenyl Acetic Acid Mustard | Cmin of chlorambucil metabolite phenyl acetic acid mustard was assesed at Cycle 1-Day 4 and Cycle 3-Day 57. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL | | Cycle 1-Day 4 and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Total Plasma Clearance (CL) of Ofatumumab | Plasma clearance is defined as the plasma volume which is totally cleared of drug per unit of time. Blood samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr). | | Posted | | Geometric Mean | 95% Confidence Interval | Milliliters/hour (mL/hr) | | Cycle 1-Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
| |
| Secondary | Area Under the Drug Plasma Concentration-time Curve From Dosing to Time Tau (AUC[0-tau]) of Ofatumumab | Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. For ofatumumab it was assesed at Cycle 1-Day 1 and Cycle 3-Day 57. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr). | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | Hours*nanogram/milliliter (hr*ng/mL | | Cycle 1-Day 1 and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | AUC(0-tau) of Chlorambucil | Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | Hr*ng/mL | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | AUC(0-tau) of Phenyl Acetic Acid Mustard | Area under the concentration time curve over the dosing interval (AUC[0-tau]) is a measure of drug exposure over time. AUC(0-tau) is defined as the area under the drug plasma/serum concentration-time curve from dosing to time tau, where tau is the length of the dosing interval of the drug. It was assesed at 1st (Cycle 1-Day 1), 4th (Cycle 1-Day 4), and 15th (Cycle 3-Day 57) chlorambucil administration. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | Hr*ng/mL | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Overall Study Arm | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-infinity]) for Ofatumumab | The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed on Cycle 1-Day 1. The samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr). | | Posted | | Geometric Mean | 95% Confidence Interval | Hr*ug/mL | | Cycle 1-Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
| |
| Secondary | AUC(0-infinity) for Chlorambucil | The total AUC or AUC0-infinity is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | Hr*ng/mL | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | AUC(0-infinity) for Phenyl Acetic Acid Mustard | The total AUC or AUC(0-infinity) is the area under the curve from time 0 extrapolated to infinite time. It was assesed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | Hr*ng/mL | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Volume of Distribution at Steady State (Vss) of Ofatumumab | Volume of distribution at steady state (Vss) is defined as the distribution of a drug between plasma and the rest of the body at steady state. Samples were collected at Cycle 1-Day1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr). | | Posted | | Geometric Mean | 95% Confidence Interval | mL | | Cycle 1-Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
| |
| Secondary | Plasma Half-life (t1/2) of Ofatumumab | t1/2 is the time required for the plasma concentration of ofatumumab to decrease by half. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr). | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | hours | | Cycle 1-Day 1 and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Plasma Half-life (t1/2) of Chlorambucil | t1/2 is the time required for the serum concentration of chlorambucil to decrease by half. Blood samples for serum concentration of chlorambucil was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | hours | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Plasma Half-life (t1/2) of Phenyl Acetic Acid Mustard | t1/2 is the time required for the plasma/serum concentration of phenylacetic acid mustard to decrease by half. Blood samples for serum concentration of phenylacetic acid mustard was collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | | Posted | | Geometric Mean | 95% Confidence Interval | hours | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
| |
| Secondary | Time to Maximum Concentration (Tmax) of Ofatumumab | Tmax is the time required for reaching maximum concentration of drug (Cmax). Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr) and Cycle 3-Day 57 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr, 168 hr). | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Median | Full Range | hours | | Cycle 1-Day 1 and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Time to Maximum Concentration (Tmax) of Chlorambucil | Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Median | Full Range | hours | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Time to Maximum Concentration (Tmax) of Phenyl Acetic Acid Mustard | Tmax is the time required for reaching maximum concentration of drug (Cmax). Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Median | Full Range | hours | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Mean Residence Time to Infinity (MRTinf) of Ofatumumab | MRTinf is the average amount of time that ofatumumab spends in the body. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr). | | Posted | | Geometric Mean | 95% Confidence Interval | hours | | Cycle 1-Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
| |
| Secondary | Mean Residence Time Inf (MRTinf) of Chlorambucil | MRTinf is the average amount of time that chlorambucil spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | hours | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Mean Residence Time Inf (MRTinf) of Phenyl Acetic Acid Mustard | MRTinf is the average amount of time that phenyl acetic acid mustard spends in the body. Blood samples were collected at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | hours | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Volume of Distribution (Vz) of Ofatumumab | Vz for ofatumumab was calculated as a ratio of the amount of ofatumumab in the body during the terminal phase to the plasma concentration during the terminal phase. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1hr, 2 hr, 24 hr, 72 hr, 120 hr). | | Posted | | Geometric Mean | 95% Confidence Interval | mL | | Cycle 1-Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
| |
| Secondary | Apparent Total Clearance of the Drug From Plasma (CL/F) for Chlorambucil | CL/F is defined as the apparent total clearance of the drug from plasma after oral administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | L/hr/m^2 | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | Apparent Volume of Distribution During Terminal Phase (Vz/F) of Chlorambucil | Vz/F of chlorambucil is defined as the apparent volume of distribution during terminal phase after non-intravenous (oral) administration of chlorambucil. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | L/m^2 | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | %AUC_extrap of Ofatumumab | %AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. Samples were collected at Cycle 1-Day 1 (pre-dose, end of infusion, 10 min, 1 hr, 2 hr, 24 hr, 72 hr, 120 hr). | | Posted | | Geometric Mean | 95% Confidence Interval | percentage of AUC after extrapolation | | Cycle 1-Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
| |
| Secondary | %AUC_extrap of Chlorambucil | %AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | percentage of AUC after extrapolation | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | %AUC_extrap of Phenyl Acetic Acid Mustard | %AUC_extrap is defined as the area under the plasma concentration-time curve extrapolated from time t to infinity as a percentage of total AUC. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | percentage of AUC after extrapolation | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
|
| Secondary | AUC (0-t) of Ofatumumab | AUC (0-t) represents the area under the concentration curve of ofatumumab in plasma from 0 to time t hours. AUC (0-t) was assessed at 168 hours and 672 hours post-dose. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | hr*µg/mL | | Cycle 1-Day 1 and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
| |
| Secondary | AUC (0-t) of Chlorambucil | AUC (0-t) represents the area under the concentration curve of chlorambucil in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | hr*ng/mL | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | AUC (0-t) of Phenyl Acetic Acid Mustard | AUC (0-t) represents the area under the concentration curve of phenyl acetic acid mustard in serum from 0 to time t hours. AUC (0-t) was assessed at 6 hours and 24 hours. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | hr*ng/mL | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Dose Normalized Cmax (Cmax/D) for Chlorambucil | Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4 and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL/mg | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | Cmax/D for Phenyl Acetic Acid Mustard | Cmax/D is defined as the maximum plasma concentration (Cmax) per unit dose. It was assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | ng/mL/mg | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D, and AUC (0-tau)/D of Chlorambucil | Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | hr*ng/mL/mg | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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| Secondary | AUC (0-6)/D, AUC(0-24)/D, AUC (0-inf)/D and AUC (0-tau)/D of Phenyl Acetic Acid Mustard | Dose adjusted AUC for the indicated time points were assessed at Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57. In each sampling, blood samples were collected at pre-dose, and 15 min, 30 min, 1 hr, 1.5 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, and 10 hr. | PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Population. | Posted | | Geometric Mean | 95% Confidence Interval | hr*ng/mL/mg | | Cycle 1-Day 1, Cycle 1-Day 4, and Cycle 3-Day 57 | | | | ID | Title | Description |
|---|
| OG000 | Ofatumumab + Chlorambucil | Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively). |
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